A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

NCT07572006 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: 95804306EDI10012026-525234-392026-525234-39-00
• Study Type: interventional
• Target: 360
• Locations: 4 countries
• Sites: 8

Brief Summary

The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose \[RP2D\]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone and/or when administered in addition to standard of care (SoC) therapy at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system). For US sites: The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose \[RP2D\]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system).

Conditions

Hematologic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

  DLT is defined as any toxicity that requires discontinuation of treatment; any toxicity resulting in dose reduction of study treatment, any toxicity resulting in a participant receiving less than (\<) 2/3 of their intended dose; any grade 5 toxicity; non-hematologic toxicity (grade 3 or 4); and unacceptable hematologic toxicity.

  Up to 28 days after first full dose of study drug

• Number of Participants with Adverse Events (AEs) by Severity

  An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 6.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.

  Up to 6 years 5 months

Secondary Outcomes (17)

• For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

  Up to first 28 days after first dose of study drug

• Serum Concentrations of JNJ-95804306

  Up to approximately 6 years 5 months

• Area Under the Curve From Time of Administration until End of Dosing Interval (AUC[t]) of JNJ-95804306

  Up to approximately 6 years 5 months

• Maximum Plasma Concentration (Cmax) of JNJ-95804306

  Up to approximately 6 years 5 months

• Minimum Plasma Concentration (Cmin) of JNJ-95804306

  Up to approximately 6 years 5 months

Study Arms (2)

Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS)

EXPERIMENTAL

Participants with relapsed/refractory (R/R) AML/HR-MDS will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to standard of care (SoC) therapy in AML (Arm A2) to determine the putative recommended phase 2 dose (RP2D) in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to SoC therapy in AML (Arm A2) at the determined RP2D regimen(s). For US sites: Participants with R/R AML/HR-MDS will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). AML SoC will not be administered for US sites.

Drug: JNJ-95804306; Drug: AML SoC

Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) or NHL monotherapy

EXPERIMENTAL

Participants with R/R CLL/SLL/NHL will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in R/R CLL/SLL (Arm B2 or B3) to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in R/R CLL/SLL (Arm B2 or B3) at the determined RP2D regimen(s). For US sites: Participants with R/R CLL/SLL/NHL will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). CLL/SLL/NHL SoC will not be administered for US sites.

Drug: JNJ-95804306; Drug: CLL/SLL SoC

Interventions

JNJ-95804306 DRUG

JNJ-95804306 will be administered orally.

Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS); Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) or NHL monotherapy

AML SoC DRUG

AML SoC will be administered subcutaneously/intravenously.

Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS)

CLL/SLL SoC DRUG

CLL/SLL SoC will be administered orally/ intravenously.

Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) or NHL monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Arm A:
• Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or very high-risk per the molecular international prognostic scoring system (IPSSM). All participants must have relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options
• Body weight greater than or equal to (\>=) 40 kilograms (kg)
• Eastern cooperative oncology group (ECOG) performance status of 0 to 2
• For Arm B:
• All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgement. Have a diagnosis of either: Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) meeting 2018 International workshop on chronic lymphocytic leukemia (iwCLL) National cancer institute (NCI) working group guidelines (Hallek 2018) that meet the following criteria:
• a. Participants must have received at least 2 prior lines of therapy; b. Have clinically measurable disease
• Body weight \>= 40 kg
• ECOG performance status of 0 to 2
• Must sign an Informed consent form (ICF)
• For US sites: Have a diagnosis of CLL/SLL that meets iwCLL, NCI Working Group Guidelines which is relapsed or refractory and requires treatment with no other approved therapies available that would be more appropriate in the investigator's judgement. a. Participants must have received at least 2 prior lines of therapy

You may not qualify if:

• For Arm A:
• Has acute promyelocytic leukemia according to world health organization (WHO) 2022 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team (SET) decision
• Need for supplemental oxygen use to maintain adequate oxygenation
• Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
• For US sites: Has acute promyelocytic leukemia according to WHO 2022 criteria or known active CNS involvement of AML/MDS
• For Arm B:
• Need for supplemental oxygen use to maintain adequate oxygenation
• Have evidence of uncontrolled systemic viral, bacterial, or fungal infection requiring initiation of parenteral treatment as medical intervention
• Developed Richter's transformation or prolymphocytic leukemia
• Known active CNS or leptomeningeal involvement of CLL/SLL/Non-Hodgkin lymphoma (NHL)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (8)

Indiana Blood & Marrow Transplantation

Indianapolis, Indiana, 46237, United States

RECRUITING

Start Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

Piscataway, New Jersey, 08854, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Sarah Cannon Cancer Institute

Nashville, Tennessee, 37203, United States

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, 3000, Australia

RECRUITING

UZ Antwerpen

Edegem, 2650, Belgium

RECRUITING

The Christie Nhs Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): May 18, 2029
• Study Completion (Estimated): September 24, 2032
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (5); GB (1); AU (1); BE (1)